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Breast Mesh Used in Two-staged Breast Reconstruction

Primary Purpose

Breast Cancer, Radiation, Breast Reconstruction

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
TiLoop Bra mesh in expander-implant breast reconstrution
sub-pectoral expander-implant breast reconstruction
Sponsored by
Tianjin Medical University Cancer Institute and Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring breast cancer, breast reconstruction, radiation, synthetic mesh

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Diagnosed with breast cancer
  2. More than 18 years old
  3. Karnofsky Performance Status (KPS) larger than 80
  4. No clinical or imaging evidence of distant metastasis
  5. BMI < 35kg/m2
  6. Patients with no or mild breast ptosis
  7. No severe deficiency in hematological, cardiovascular system, no immune-deficiency, no severe abnormal liver or kidney function.

  8. Mental Health Patient

    -

    Exclusion Criteria:

1. Patients with distant metastasis of breast cancer or local recurrence; 2. Past ipsilateral breast/chest wall radiation; 3. Inflammatory breast cancer, stage IV breast cancer 4. History of severe allergic or specific constitution; 5. Mental illness; 6. Drug/alcohol abuse; 7. Pregnancy, lactation, or impregnated during the trial period; 8. Non-eligible to the study enrollment based on researchers' discretion

-

Sites / Locations

  • MD Anderson Cancer CenterRecruiting
  • Gansu Provincial Cancer HospitalRecruiting
  • Jilin Cancer HospitalRecruiting
  • Tianjin Medical University Cancer Institute and HospitalRecruiting
  • Zhejiang Provincial People's HospitalRecruiting
  • Technical University of MunichRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Breast Reconstruction with breast mesh

Breast Reconstruction without breast mesh

Arm Description

The tissue expander-implant reconstruction with TiLoop Bra mesh.

The tissue expander-implant reconstruction without TiLoop Bra mesh. The tissue expander is placed sub-pectoral and covered by muscle/fascia.

Outcomes

Primary Outcome Measures

Complication Rates
complications related to the reconstructed breast, including flap complications, capsular contracture, surgical site infection, prosthetic malposition/extrusion, reconstruction failure, etc.
Expansion Efficiency
percentage of average injected saline volume to total volume (E=average volume/ total volume）through study completion, an average of 1 year

Secondary Outcome Measures

number of revision surgery
To record the rate of surgical revision events on the breast including but not limited to fat tranplantation, reduction mammoplasty/mastompexy, contralateral augmentation,
aesthetic outcome graded by Harris evaluation score and Breast-Q questionaire
Harris evaluation score was used to evaluate the aesthetic outcome of patients' reconstructed breasts, which was scored as "excellent," "good," "fair," "poor". Breast-Q questionaire was also used to evaluate the aesthetic outcome of patients' reconstructed breast.
psychological evaluation by Breast-Q questionnaire
We use the Breast-Q questionnaire to evaluate patients' satisfaction via the reconstruction module of BREAST-Q.
total cost
total cost in RMB per captia
number of occurrence of deep venous thrombosis
post-operative occurrence of deep venous thrombosis
number of occurrence of non-surgical site infection
post-operative occurrence of non-surgical site infection including but not limited pneumonia, urinary tract infection, etc.

Full Information

First Posted
June 10, 2021
Last Updated
July 19, 2021
Sponsor
Tianjin Medical University Cancer Institute and Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04967976
Brief Title
Breast Mesh Used in Two-staged Breast Reconstruction
Official Title
A Prospective Randomized and Controlled Study of Efficacy and Safety of TiLOOP® Bra Mesh in Patients With Expander-Implant Breast Reconstruction.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2021 (Anticipated)
Primary Completion Date
August 1, 2023 (Anticipated)
Study Completion Date
August 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tianjin Medical University Cancer Institute and Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is the first prospective randomized and controlled study on the efficacy and safety of TiLOOP® Bra mesh in patients with expander-implant breast reconstruction. The investigators hypothesize that incoporating TiLOOP Bra mesh with tissue expanders will reduce the rates of capsular contraction, improve the efficiency of expansion and provide better aesthetic result.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Radiation, Breast Reconstruction, Synthetic Mesh
Keywords
breast cancer, breast reconstruction, radiation, synthetic mesh

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Breast Reconstruction with breast mesh
Arm Type
Experimental
Arm Description
The tissue expander-implant reconstruction with TiLoop Bra mesh.
Arm Title
Breast Reconstruction without breast mesh
Arm Type
Active Comparator
Arm Description
The tissue expander-implant reconstruction without TiLoop Bra mesh. The tissue expander is placed sub-pectoral and covered by muscle/fascia.
Intervention Type
Procedure
Intervention Name(s)
TiLoop Bra mesh in expander-implant breast reconstrution
Intervention Description
The tissue expander is inserted with TiLoop Bra mesh in the first stage of reconstruction immediately after nipple/skin-sparing mastectomy. The tissue expander is placed sub-pectoral.
Intervention Type
Procedure
Intervention Name(s)
sub-pectoral expander-implant breast reconstruction
Intervention Description
The tissue expander is inserted without TiLoop Bra mesh in the first stage of reconstruction immediately after nipple/skin-sparing mastectomy. The tissue expander is placed sub-pectoral and covered by muscle/fascia.
Primary Outcome Measure Information:
Title
Complication Rates
Description
complications related to the reconstructed breast, including flap complications, capsular contracture, surgical site infection, prosthetic malposition/extrusion, reconstruction failure, etc.
Time Frame
up to 24 months after surgery
Title
Expansion Efficiency
Description
percentage of average injected saline volume to total volume (E=average volume/ total volume）through study completion, an average of 1 year
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
number of revision surgery
Description
To record the rate of surgical revision events on the breast including but not limited to fat tranplantation, reduction mammoplasty/mastompexy, contralateral augmentation,
Time Frame
from the completion of expander exchange up to 24 months after surgery
Title
aesthetic outcome graded by Harris evaluation score and Breast-Q questionaire
Description
Harris evaluation score was used to evaluate the aesthetic outcome of patients' reconstructed breasts, which was scored as "excellent," "good," "fair," "poor". Breast-Q questionaire was also used to evaluate the aesthetic outcome of patients' reconstructed breast.
Time Frame
from the completion of expander exchange up to 24 months after surgery
Title
psychological evaluation by Breast-Q questionnaire
Description
We use the Breast-Q questionnaire to evaluate patients' satisfaction via the reconstruction module of BREAST-Q.
Time Frame
from the completion of expander exchange up to 24 months after surgery
Title
total cost
Description
total cost in RMB per captia
Time Frame
from expander implation up to the completion of expander exchange,through study completion, an average of 1 year
Title
number of occurrence of deep venous thrombosis
Description
post-operative occurrence of deep venous thrombosis
Time Frame
from expander implation up to the completion of expander exchange, through study completion, an average of 1 year
Title
number of occurrence of non-surgical site infection
Description
post-operative occurrence of non-surgical site infection including but not limited pneumonia, urinary tract infection, etc.
Time Frame
from expander implation up to the completion of expander exchange, through study completion, an average of 1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosed with breast cancer More than 18 years old Karnofsky Performance Status (KPS) larger than 80 No clinical or imaging evidence of distant metastasis BMI < 35kg/m2 Patients with no or mild breast ptosis No severe deficiency in hematological, cardiovascular system, no immune-deficiency, no severe abnormal liver or kidney function. Mental Health Patient - Exclusion Criteria: 1. Patients with distant metastasis of breast cancer or local recurrence; 2. Past ipsilateral breast/chest wall radiation; 3. Inflammatory breast cancer, stage IV breast cancer 4. History of severe allergic or specific constitution; 5. Mental illness; 6. Drug/alcohol abuse; 7. Pregnancy, lactation, or impregnated during the trial period; 8. Non-eligible to the study enrollment based on researchers' discretion -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jian Yin
Phone
+86-22-23340123
Ext
1174
Email
yinjian@tjmuch.com
First Name & Middle Initial & Last Name or Official Title & Degree
Bowen Ding
Phone
+86-22-23340123
Ext
1171
Email
ding_x87@126.com
Facility Information:
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Edward Chang
Facility Name
Gansu Provincial Cancer Hospital
City
Lanzhou
State/Province
Gansu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suisheng Yang
Facility Name
Jilin Cancer Hospital
City
Ch'ang-ch'un
State/Province
Jilin
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guiying Xu
Facility Name
Tianjin Medical University Cancer Institute and Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bowen Ding
Phone
18822077799
Email
ding_x87@126.com
First Name & Middle Initial & Last Name & Degree
Jian Yin
First Name & Middle Initial & Last Name & Degree
Bowen Ding
Facility Name
Zhejiang Provincial People's Hospital
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xuli Meng
Facility Name
Technical University of Munich
City
Munich
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefan Paepke

12. IPD Sharing Statement

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Breast Mesh Used in Two-staged Breast Reconstruction

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